N/A
N=389
Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)
Condition of Patient 3 Years After FESS-operation
Bottom Line
View on ClinicalTrials.gov: NCT01777425 ↗Enrolled (actual)
389
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Control Status of Patients With Rhinosinusitis — 19.5; 36.8; 43.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Control Status of Patients With Rhinosinusitis |
19.5; 36.8; 43.7 | — |
| SECONDARY Control Nasal Endoscopy |
8.6; 24.7; 66.7 | — |
Summary
State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS) provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can alleviate symptoms associated with AR and RS, and most patients with RS benefit from endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR and CRS continue to experience bothersome symptoms despite adequate treatment. This group with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge (3).
Eligibility Criteria
Inclusion Criteria
- Patients that have undergone bilateral ESS for inflammatory sinonasal disease, without additional sino-nasal surgery after the ESS.
- Age > 18 and < 75 years.
- Written informed consent
- Dutch, French or English speaking patients
Exclusion Criteria
- Unilateral ESS
- Benign and malignant tumor disease
- Patient with a psychiatric, addictive, or any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire
- Lack of knowledge of Dutch, French or English
Data sourced from ClinicalTrials.gov (NCT01777425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.